Jurors hear of J&J exec warnings over faulty hip implants

Michael Kelly, attorney for plaintiff Loren Kransky, holds up an ASR XL hip implant made by Johnson & Johnson during his opening statement to the jury at the trial of Kransky v. DePuy, at California Superior Court in Los Angeles on Friday. J&J failed to warn doctors of the risks of defective metal hip implants that it didnât test properly, a lawyer told a Los Angeles jury in the first of 10,000 lawsuits over the device to go to trial. Patrick T. Fallon/Bloomberg

Almost a year before Johnson & Johnson’s DePuy unit recalled 93,000 metal hip implants, a top marketing executive said the company should consider that action, according to an internal e-mail shown to jurors.

Paul Berman, DePuy’s director of hip marketing, wrote Sept. 18, 2009, that he wanted to “reiterate my concern” over safety of the ASR device, given mounting failures. Jurors, at the first of 10,000 lawsuits to go to trial, saw several e-mails today from marketers before the recall on Aug. 24, 2010.

Berman discussed a recommendation to “discontinue the product from all but 10 surgeons because of failure rates with the broader universe,” according to the e-mail shown to state court jurors in Los Angeles.

“If the company feels the safety profile of the platform is not acceptable among the majority of surgeons it seems we should consider recalling it altogether,” Berman wrote.

Jurors are weighing the lawsuit of Loren Kransky, 65, a retired prison guard who claims that DePuy defectively designed the device. Kransky’s lawyers claim that surgeons who implanted the ASR complained for years before the recall about device failures, and DePuy failed to warn properly of the risks.

J&J, the world’s largest seller of health-care products, denies it defectively designed the device or that it contributed to Kransky’s health problems. J&J is based in New Brunswick.

In an opening statement on Jan. 25, J&J lawyer Alexander Calfo said Kransky’s lawyers took e-mails out of context to “paint a picture about a company that simply isn’t true.”

Sampson wrote that he saw an ad on the cover of Orthopedics Today claiming 99.2 percent survivorship for ASR patients.

“It was difficult to read the ad considering my failure rate is in double digits,” Sampson wrote on July 28, 2008. He said another doctor’s “are worse and other orthos I have talked with stopped using it all together because of pain and fibrous ingrowth.” Sampson added “I don’t believe the failures are due solely to technique.”

Vail forwarded the e-mail to another surgeon who also helped design the ASR, Thomas Schmalzried, who responded, “Using ‘surgical technique’ to explain failures to a surgeon is an uphill fight.”

Jurors also saw an e-mail chain involving Tom Fehring, a North Carolina surgeon who had advocated studying ASR patients. Berman sent marketing materials to Fehring about another J&J hip, the Pinnacle, according to an e-mail. Fehring complimented Berman on the materials.

Berman e-mailed Rhee in January 2009 stating he had “sent all Pinn design surgeons the new Pinn brochure with a letter telling them we plan to continue promoting it. Should make them back off asr a bit.”

On March 14, 2010, Berman wrote an e-mail to a colleague, according to testimony.

“I want to reiterate my concerns with the safety of the ASR platform,” he wrote. “With growing chatter in the market and commentary” from a British surgeon and others, “I still remain concerned with the safety of this product,” he said.

“As a marketing professional, I do not make product safety decisions, but I do have an obligation as an employee of J&J and DePuy to make it know when I do not feel comfortable,” he wrote.

He referred to four earlier e-mails he sent, including the one in September 2009 suggesting a possible recall.
Bloomberg